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To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.

The ProActive Carem is a premium Prophylaxis Paste with fluoride that gently removes dental plaque and staining. It is a unique blend of polishing and cleaning agents designed for professional application during standard dental practice hygiene procedures.

This document is a 510(k) premarket notification for a dental device, specifically a "ProActive Care™ Prophylaxis Paste with Fluoride."

The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness.

Crucially, a 510(k) submission typically does not include new clinical studies proving device efficacy or meeting specific acceptance criteria in the way a pharmaceutical drug or a high-risk medical device might. Instead, substantial equivalence is often established through non-clinical performance testing, comparisons to predicate devices, and sometimes existing clinical literature.

Therefore, many of the requested items regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this type of regulatory submission for this specific device.

Based on the provided document, here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance:

The document does not specify quantitative acceptance criteria or a study that "proves the device meets the acceptance criteria" in the way one might expect for a novel device undergoing extensive clinical trials. Instead, the device's acceptability is based on its substantial equivalence to predicate devices already on the market.

Substantial Equivalence Determination (Section 8):
The ProActive Care™ Prophylaxis Paste is claimed to be substantially equivalent to the following products:

• Nupro® T Prophylaxis Paste with Fluoride and Triclosan (K000169)
• ProClude® (K002989)
• 3M™ Clinpro™ Prophy Paste (K990482)

The implication is that because these predicate devices are considered safe and effective for their intended use, and ProActive Care™ is substantially equivalent, it too is considered safe and effective. The criteria for demonstrating substantial equivalence would primarily involve comparing material composition, intended use, and non-clinical performance (e.g., abrasiveness, fluoride release, stability) to the predicate devices. However, the details of these comparisons are not present in this summary.

Detailed Breakdown of Requested Information:

1. A table of acceptance criteria and the reported device performance:

   • Not Applicable / Not Provided in this document. The document does not contain a table of explicit, quantitative acceptance criteria or reported performance data in the context of a dedicated clinical study for this device. The "performance" is implicitly deemed acceptable by its substantial equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable / Not Provided in this document. This document does not describe a clinical study with a test set of human subjects or data. The submission relies on demonstrating similarity to existing, approved devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not Applicable / Not Provided in this document. There is no "ground truth" establishment in the context of a diagnostic or predictive device. The regulatory body (FDA) reviews the submission and makes a determination of substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable / Not Provided in this document. No test set or adjudication process for diagnostic outcomes is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not Applicable / Not Provided in this document. This device is a prophylaxis paste, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable / Not Provided in this document. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not Applicable / Not Provided in this document. No ground truth for diagnostic validation is relevant here. The "ground truth" for the device's acceptability is its demonstrated substantial equivalence to predicate devices based on regulatory review of non-clinical data (e.g., chemical composition, physical properties) and intended use.

8. The sample size for the training set:

   • Not Applicable / Not Provided in this document. This is not a machine learning or AI device that would require a training set.

9. How the ground truth for the training set was established:

   • Not Applicable / Not Provided in this document. Not an AI device.

Summary of what the document does provide:

• Device Name: ProActive Care™ Prophylaxis Paste with Fluoride
• Intended Use: "To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment." (Page 1 and Page 4)
• Classification Name: Oral cavity abrasive polishing agent
• Regulatory Class: I
• Predicate Devices: Nupro® T Prophylaxis Paste with Fluoride and Triclosan (K000169), ProClude® (K002989), 3M™ Clinpro™ Prophy Paste (K990482) (Page 2)
• Decision: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. (Page 3)

Ask a specific question about this device

Butler GUM Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures as a part of a professionally administered dental prophylaxis treatment. Secondarily, Butler GUM® Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity, post-scaling and root planing.

Bulter GUM® Prophylaxsis Paste with NovaMin® is intended for use in a professionally administered cleaning and polishing procedure during the prophylaxis treatment. The NovaMin® in the paste reduces sensitivity by occluding dentinal tubules.

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary for a prophylaxis paste, primarily discussing its substantial equivalence to a predicate device and its intended use. It does not contain the details you've requested about device performance, study designs, expert involvement, or ground truth establishment.

Ask a specific question about this device